Methods and apparatus for efficient purging

ABSTRACT

A method of inhibiting a flow of a purging fluid from a tissue visualization device comprises positioning an imaging hood attached to a distal end of a flexible elongate shaft in proximity to a tissue region to be visualized The method also comprises introducing the purging fluid into an inflation member suspended within an open area of the imaging hood. The inflation member includes at least one aperture on a proximal portion of the inflation member. The method also comprises inflating the inflation member to a partially inflated state in which the inflation member is circumferentially separated from an inner surface of the hood to form an annular flow path for the purging fluid from the at least one aperture, between the inner surface of the hood and the inflation member, and into fluid communication with an environment external to the hood. The method also comprising inflating the inflation member to a blocking inflated state in which the inflation member expands into contact with the imaging hood to block the flow from the at least one aperture to the annular flow path.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.12/499,681, filed Jul. 8, 2009 which claims the benefit of priority toU.S. Prov. Pat. App. 61/079,414 filed Jul. 9, 2008, which isincorporated herein by reference in its entirety. U.S. patentapplication Ser. No. 12/499,681 is also a continuation-in-part of U.S.patent application Ser. No. 11/259,498, filed Oct. 25, 2005 (now U.S.Pat. No. 7,860,555), which is incorporated by reference herein in itsentirety.

FIELD OF THE INVENTION

The present invention relates generally to medical devices used foraccessing, visualizing, and/or treating regions of tissue within a body.More particularly, the present invention relates to methods andapparatus for efficiently purging opaque fluids from an intravascularvisualization system to facilitate visualization and/or treatment of thetissue.

BACKGROUND OF THE INVENTION

Conventional devices for accessing and visualizing interior regions of abody lumen are known. For example, various catheter devices aretypically advanced within a patient's body, e.g., intravascularly, andadvanced into a desirable position within the body. Other conventionalmethods have utilized catheters or probes having position sensorsdeployed within the body lumen, such as the interior of a cardiacchamber. These types of positional sensors are typically used todetermine the movement of a cardiac tissue surface or the electricalactivity within the cardiac tissue. When a sufficient number of pointshave been sampled by the sensors, a “map” of the cardiac tissue may begenerated.

Another conventional device utilizes an inflatable balloon which istypically introduced intravascularly in a deflated state and theninflated against the tissue region to be examined. Imaging is typicallyaccomplished by an optical fiber or other apparatus such as electronicchips for viewing the tissue through the membrane(s) of the inflatedballoon. Moreover, the balloon must generally be inflated for imaging.Other conventional balloons utilize a cavity or depression formed at adistal end of the inflated balloon. This cavity or depression is pressedagainst the tissue to be examined and is flushed with a clear fluid toprovide a clear pathway through the blood.

However, many of the conventional catheter imaging systems lack thecapability to provide therapeutic treatments or are difficult tomanipulate in providing effective therapies. For instance, the treatmentin a patient's heart for atrial fibrillation is generally made difficultby a number of factors, such as visualization of the target tissue,access to the target tissue, and instrument articulation and management,amongst others.

Conventional catheter techniques and devices, for example such as thosedescribed in U.S. Pat. Nos. 5,895,417; 5,941,845; and 6,129,724, used onthe epicardial surface of the heart may be difficult in assuring atransmural lesion or complete blockage of electrical signals. Inaddition, current devices may have difficulty dealing with varyingthickness of tissue through which a transmural lesion is desired.

Conventional accompanying imaging devices, such as fluoroscopy, areunable to detect perpendicular electrode orientation, catheter movementduring the cardiac cycle, and image catheter position throughout lesionformation. The absence of real-time visualization also poses the risk ofincorrect placement and ablation of structures such as sinus node tissuewhich can lead to fatal consequences.

BRIEF SUMMARY OF THE INVENTION

A tissue imaging and manipulation apparatus that may be utilized forprocedures within a body lumen, such as the heart, in whichvisualization of the surrounding tissue is made difficult, if notimpossible, by medium contained within the lumen such as blood, isdescribed below. Generally, such a tissue imaging and manipulationapparatus comprises an optional delivery catheter or sheath throughwhich a deployment catheter and imaging hood may be advanced forplacement against or adjacent to the tissue to be imaged.

The deployment catheter may define a fluid delivery lumen therethroughas well as an imaging lumen within which an optical imaging fiber orassembly may be disposed for imaging tissue. When deployed, the imaginghood may be expanded into any number of shapes, e.g., cylindrical,conical as shown, semi-spherical, etc., provided that an open area orfield is defined by the imaging hood. The open area is the area withinwhich the tissue region of interest may be imaged. The imaging hood mayalso define an atraumatic contact lip or edge for placement or abutmentagainst the tissue region of interest. Moreover, the distal end of thedeployment catheter or separate manipulatable catheters may bearticulated through various controlling mechanisms such as push-pullwires manually or via computer control

The deployment catheter may also be stabilized relative to the tissuesurface through various methods. For instance, inflatable stabilizingballoons positioned along a length of the catheter may be utilized, ortissue engagement anchors may be passed through or along the deploymentcatheter for temporary engagement of the underlying tissue.

In operation, after the imaging hood has been deployed, fluid may bepumped at a positive pressure through the fluid delivery lumen until thefluid fills the open area completely and displaces any blood from withinthe open area. The fluid may comprise any biocompatible fluid, e.g.,saline, water, plasma, Fluorinert™, etc., which is sufficientlytransparent to allow for relatively undistorted visualization throughthe fluid. The fluid may be pumped continuously or intermittently toallow for image capture by an optional processor which may be incommunication with the assembly.

In an exemplary variation for imaging tissue surfaces within a heartchamber containing blood, the tissue imaging and treatment system maygenerally comprise a catheter body having a lumen defined therethrough,a visualization element disposed adjacent the catheter body, thevisualization element having a field of view, a transparent fluid sourcein fluid communication with the lumen, and a barrier or membraneextendable from the catheter body to localize, between the visualizationelement and the field of view, displacement of blood by transparentfluid that flows from the lumen, and an instrument translatable throughthe displaced blood for performing any number of treatments upon thetissue surface within the field of view. The imaging hood may be formedinto any number of configurations and the imaging assembly may also beutilized with any number of therapeutic tools which may be deployedthrough the deployment catheter.

More particularly in certain variations, the tissue visualization systemmay comprise components including the imaging hood, where the hood mayfurther include a membrane having a main aperture and additionaloptional openings disposed over the distal end of the hood. Anintroducer sheath or the deployment catheter upon which the imaging hoodis disposed may further comprise a steerable segment made of multipleadjacent links which are pivotably connected to one another and whichmay be articulated within a single plane or multiple planes. Thedeployment catheter itself may be comprised of a multiple lumenextrusion, such as a four-lumen catheter extrusion, which is reinforcedwith braided stainless steel fibers to provide structural support. Theproximal end of the catheter may be coupled to a handle for manipulationand articulation of the system.

To provide visualization, an imaging element such as a fiberscope orelectronic imager such as a solid state camera, e.g., CCD or CMOS, maybe mounted, e.g., on a shape memory wire, and positioned within or alongthe hood interior. A fluid reservoir and/or pump (e.g., syringe,pressurized intravenous bag, etc.) may be fluidly coupled to theproximal end of the catheter to hold the translucent fluid such assaline or contrast medium as well as for providing the pressure toinject the fluid into the imaging hood.

In clearing the hood of blood and/or other bodily fluids, it isgenerally desirable to purge the hood in an efficient manner byminimizing the amount of clearing fluid, such as saline, introduced intothe hood and thus into the body. As excessive saline delivered into theblood stream of patients with poor ventricular function may increase therisk of heart failure and pulmonary edema, minimizing or controlling theamount of saline discharged during various therapies, such as atrialfibrillation ablation, atrial flutter ablation, transseptal puncture,etc. may be generally desirable.

One variation of an imaging hood may incorporate an internal diaphragm,which may be transparent, attached to the inner wall of the hood aboutits circumference. The diaphragm may be fabricated from a transparentelastomeric membrane similar to the material of the hood (such aspolyurethane, Chronoflex™, latex, etc) and may define one or moreapertures through which saline fluid introduced into the hood may passthrough the diaphragm and out through the main aperture to clear bloodfrom the open field within the hood. The one or more apertures may havea diameter of between, e.g., 1 mm to 0.25 mm.

Flow of the saline fluid out of the hood through the main aperture maycontinue under relatively low fluid pressure conditions as saline isintroduced from the catheter shaft, through the diaphragm apertures, andout of the main aperture. Upon the application of a relatively higherfluid pressure, the diaphragm may be pushed distally within the hooduntil it extends or bulges distally to block the main aperture untilfluid flow out of the hood is reduced or completely stopped. With theaperture blocked, the hood may retain the purging fluid within tofacilitate visualization through the fluid of the underlying tissue.Thus, the hood may be panned around a target tissue region withsustained visualization to reduce the amount of saline that isintroduced into a patient's heart or bloodstream. Once the fluidpressure of the purging fluid is reduced, the diaphragm may retract tounblock the aperture and thus allow for the flow of the purging fluidagain through the diaphragm apertures and main aperture. Alternatively,one or more unidirectional valves may be positioned over the diaphragmto control the flow of the purging fluid through the hood and out themain aperture. Other variations may incorporate an internal inflationmember or pouch which may be positioned within the hood and whichcontrols the outflow of the purged saline based on the fluid pressurewithin the pouch.

In yet other variations, one or more portions of the hood support strutsmay extend at least partially within the distal chamber such that thesaline within the distal chamber can be electrically charged, such aswith RF energy, when the support struts are coupled to an RF generator.This allows the saline encapsulated in the distal chamber to function asa virtual electrode by conducting the discharged energy to theunderlying visualized tissue for treatments, such as tissue ablation.

Yet another variation may incorporate an electrode, such as ring-shapedelectrode, within the hood which defines a central lumen therethrough.The central lumen may define one or more fluid apertures proximally ofthe electrode which open to the hood interior in a circumferentialpattern around an outer surface of the lumen. With the positioning of,e.g., a fiberscope, within the lumen and its distal end positionedadjacent to or distal to the electrode, the distal opening of the lumenmay be obstructed by the fiberscope such that the purging fluidintroduced through the lumen flows in an annular space between thefiberscope and the lumen and is forced to flow sideways into the hoodthrough the one or more fluid apertures while the distal opening of thelumen remains obstructed by the fiberscope.

Another variation of the hood may incorporate one or more protrusions orprojections extending from a distal membrane over the hood. Theseprotrusions or projections may extend distally adjacent to acorresponding unidirectional valve which has overlapping leaflets. Asthe hood is filled with the purging fluid, flow through the valves isinhibited or prevented by the overlapping leaflets but as the distalface of the hood membrane is pressed against a surface of tissue to bevisualized and/or treated, the protrusions or projections pressingagainst the tissue surface may force the valve leaflets to separatetemporarily, thus allowing the passage of saline out through the valvesto clear any blood within the hood as well as any blood between membraneand the tissue surface.

In yet another variation, an imaging hood may be configured to form arecirculating flow inside the hood. The purging fluid may be introduced(e.g., injected) as well as withdrawn from the imaging hood interiorthrough two different lumens in the catheter shaft. For instance, thefluid may be introduced by an inlet lumen which injects the fluid alonga first path into the hood while the recirculating fluid may bewithdrawn by suction through a separate outlet lumen. By keeping arelatively higher volume flow rate in the inlet lumen for injecting thepurging fluid than the flow rate in the outlet lumen for withdrawing it,a considerable amount of purging fluid may be conserved resulting inefficient hood purging. Another variation may incorporate a suctionlumen, e.g., a pre-bent lumen, extending from the catheter directly tothe main aperture. This particular variation may allow for the directevacuation of blood through a lumen opening at a particular locationalong the main aperture where the in-flow of blood (or other opaquefluids) is particularly high.

Yet another variation may utilize a hood partitioned into multiplechambers which are in fluid communication with individual correspondingfluid lumens defined through the catheter. Each of the chambers may beseparated by corresponding transparent barriers which extend along thelength of hood. Each of the different chambers may have a correspondingaperture. Efficient purging and reduction of saline discharged mayachieved when purging can be selectively stopped once a particularchamber establishes optical clarity. This can be done manually by theoperator or through automation by a processor incorporated within thesystem.

Another variation may incorporate an expandable distal membrane whichprojects distally from the hood and is sufficiently soft to conformagainst the underlying contacted tissue. With the membrane defining oneor more hood apertures, the purging fluid may enter within the hood andexit through the hood apertures into an intermediate chamber. Thepurging fluid may exit the intermediate chamber through at least onecentral aperture. In the event that the hood contacts against a surfaceof tissue at a non-perpendicular angle, the distal membrane may stillconform to the tissue surface.

In yet another variation, an imaging hood may have a distal membranewithout an aperture and which may be filled with the purging fluid oncedesirably positioned within the subject's body in proximity to thetissue region to be visualized and/or treated. Once a tissue region tobe treated has been located by the hood, a piercing instrument may beadvanced through the hood from the catheter to puncture through thedistal membrane at a desired site. This may form a puncture aperturethrough which the purging fluid may escape. Hence, purging is onlyperformed at locations where instruments are passed out of the imaginghood thus reducing the amount of saline discharged out of the hood.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a side view of one variation of a tissue imaging apparatusduring deployment from a sheath or delivery catheter.

FIG. 1B shows the deployed tissue imaging apparatus of FIG. 1A having anoptionally expandable hood or sheath attached to an imaging and/ordiagnostic catheter.

FIG. 1C shows an end view of a deployed imaging apparatus.

FIGS. 2A and 2B show one example of a deployed tissue imager positionedagainst or adjacent to the tissue to be imaged and a flow of fluid, suchas saline, displacing blood from within the expandable hood.

FIGS. 3A and 3B show examples of various visualization imagers which maybe utilized within or along the imaging hood.

FIGS. 4A and 4B show perspective and end views, respectively, of animaging hood having at least one layer of a transparent elastomericmembrane over the distal opening of the hood.

FIGS. 5A and 5B show perspective and end views, respectively, of animaging hood which includes a membrane with an aperture definedtherethrough and a plurality of additional openings defined over themembrane surrounding the aperture.

FIGS. 6A and 6B show side views of one variation of the imaging hoodhaving an internal diaphragm in which the flow of the purging fluidthrough the hood can be controlled or stopped by varying its fluidpressure.

FIGS. 7A and 7B show side views of another variation of the hood havingan inflatable membrane positioned within the hood which may be used tocontrol or stop the purging fluid.

FIG. 8 shows a side view of another variation having an internalmembrane which comprises one or more unidirectional valves to controlthe flow of the purging fluid.

FIGS. 9A and 9B show side views of the one or more unidirectional valvesin an opened and closed configuration, respectively, for controlling thefluid flow therethrough.

FIGS. 10A and 10B show perspective and cross-sectional perspectiveviews, respectively, of yet another variation where one or more sideports may be defined within the hood for uniformly purging blood fromthe hood interior.

FIG. 11 shows a side view of another variation of the hood having adistal membrane which defines one or more projections which extenddistally to actuate the opening of one or more corresponding valves.

FIGS. 12A and 12B show detail side views of the one or more projectionswhich actuate the opening of a corresponding valve when contactedagainst a tissue surface.

FIG. 13 shows a side view of another variation which incorporates arecirculating flow within the hood.

FIG. 14 shows a side view of another variation which incorporates asuction lumen for selective evacuation at or near the main aperture.

FIG. 15 shows a side view of another variation which comprises multiplechambers each defining an aperture to form a uniform flow through thehood.

FIG. 16 illustrates a flow chart of one example for automating theselective purging of individual chambers to reduce saline discharge fromthe hood.

FIGS. 17A and 17B show side views of another variation whichincorporates a distal chamber to facilitate the efficient purging ofblood from the hood when contact against a tissue surface is at anangle.

FIG. 18 shows a side view of another variation which comprises apiercing instrument, such as a needle, for forming an aperture throughwhich the purging fluid may escape.

DETAILED DESCRIPTION OF THE INVENTION

A tissue-imaging and manipulation apparatus described herein is able toprovide real-time images in vivo of tissue regions within a body lumensuch as a heart, which is filled with blood flowing dynamicallytherethrough and is also able to provide intravascular tools andinstruments for performing various procedures upon the imaged tissueregions. Such an apparatus may be utilized for many procedures, e.g.,facilitating transseptal access to the left atrium, cannulating thecoronary sinus, diagnosis of valve regurgitation/stenosis,valvuloplasty, atrial appendage closure, arrhythmogenic focus ablation,among other procedures.

One variation of a tissue access and imaging apparatus is shown in thedetail perspective views of FIGS. 1A to 1C. As shown in FIG. 1A, tissueimaging and manipulation assembly 10 may be delivered intravascularlythrough the patient's body in a low-profile configuration via a deliverycatheter or sheath 14. In the case of treating tissue, it is generallydesirable to enter or access the left atrium while minimizing trauma tothe patient. To non-operatively effect such access, one conventionalapproach involves puncturing the intra-atrial septum from the rightatrial chamber to the left atrial chamber in a procedure commonly calleda transseptal procedure or septostomy. For procedures such aspercutaneous valve repair and replacement, transseptal access to theleft atrial chamber of the heart may allow for larger devices to beintroduced into the venous system than can generally be introducedpercutaneously into the arterial system.

When the imaging and manipulation assembly 10 is ready to be utilizedfor imaging tissue, imaging hood 12 may be advanced relative to catheter14 and deployed from a distal opening of catheter 14, as shown by thearrow. Upon deployment, imaging hood 12 may be unconstrained to expandor open into a deployed imaging configuration, as shown in FIG. 1B.Imaging hood 12 may be fabricated from a variety of pliable orconformable biocompatible material including but not limited to, e.g.,polymeric, plastic, or woven materials. One example of a woven materialis Kevlar® (E. I. du Pont de Nemours, Wilmington, Del.), which is anaramid and which can be made into thin, e.g., less than 0.001 in.,materials which maintain enough integrity for such applicationsdescribed herein. Moreover, the imaging hood 12 may be fabricated from atranslucent or opaque material and in a variety of different colors tooptimize or attenuate any reflected lighting from surrounding fluids orstructures, i.e., anatomical or mechanical structures or instruments. Ineither case, imaging hood 12 may be fabricated into a uniform structureor a scaffold-supported structure, in which case a scaffold made of ashape memory alloy, such as Nitinol, or a spring steel, or plastic,etc., may be fabricated and covered with the polymeric, plastic, orwoven material. Hence, imaging hood 12 may comprise any of a widevariety of barriers or membrane structures, as may generally be used tolocalize displacement of blood or the like from a selected volume of abody lumen or heart chamber. In exemplary embodiments, a volume withinan inner surface 13 of imaging hood 12 will be significantly less than avolume of the hood 12 between inner surface 13 and outer surface 11.

Imaging hood 12 may be attached at interface 24 to a deployment catheter16 which may be translated independently of deployment catheter orsheath 14. Attachment of interface 24 may be accomplished through anynumber of conventional methods. Deployment catheter 16 may define afluid delivery lumen 18 as well as an imaging lumen 20 within which anoptical imaging fiber or assembly may be disposed for imaging tissue.When deployed, imaging hood 12 may expand into any number of shapes,e.g., cylindrical, conical as shown, semi-spherical, etc., provided thatan open area or field 26 is defined by imaging hood 12. The open area 26is the area within which the tissue region of interest may be imaged.Imaging hood 12 may also define an atraumatic contact lip or edge 22 forplacement or abutment against the tissue region of interest. Moreover,the diameter of imaging hood 12 at its maximum fully deployed diameter,e.g., at contact lip or edge 22, is typically greater relative to adiameter of the deployment catheter 16 (although a diameter of contactlip or edge 22 may be made to have a smaller or equal diameter ofdeployment catheter 16). For instance, the contact edge diameter mayrange anywhere from 1 to 5 times (or even greater, as practicable) adiameter of deployment catheter 16. FIG. 1C shows an end view of theimaging hood 12 in its deployed configuration. Also shown are thecontact lip or edge 22 and fluid delivery lumen 18 and imaging lumen 20.

As seen in the example of FIGS. 2A and 2B, deployment catheter 16 may bemanipulated to position deployed imaging hood 12 against or near theunderlying tissue region of interest to be imaged, in this example aportion of annulus A of mitral valve MV within the left atrial chamber.As the surrounding blood 30 flows around imaging hood 12 and within openarea 26 defined within imaging hood 12, as seen in FIG. 2A, theunderlying annulus A is obstructed by the opaque blood 30 and isdifficult to view through the imaging lumen 20. The translucent fluid28, such as saline, may then be pumped through fluid delivery lumen 18,intermittently or continuously, until the blood 30 is at leastpartially, and preferably completely, displaced from within open area 26by fluid 28, as shown in FIG. 2B.

Although contact edge 22 need not directly contact the underlyingtissue, it is at least preferably brought into close proximity to thetissue such that the flow of clear fluid 28 from open area 26 may bemaintained to inhibit significant backflow of blood 30 back into openarea 26. Contact edge 22 may also be made of a soft elastomeric materialsuch as certain soft grades of silicone or polyurethane, as typicallyknown, to help contact edge 22 conform to an uneven or rough underlyinganatomical tissue surface. Once the blood 30 has been displaced fromimaging hood 12, an image may then be viewed of the underlying tissuethrough the clear fluid 30. This image may then be recorded or availablefor real-time viewing for performing a therapeutic procedure. Thepositive flow of fluid 28 may be maintained continuously to provide forclear viewing of the underlying tissue. Alternatively, the fluid 28 maybe pumped temporarily or sporadically only until a clear view of thetissue is available to be imaged and recorded, at which point the fluidflow 28 may cease and blood 30 may be allowed to seep or flow back intoimaging hood 12. This process may be repeated a number of times at thesame tissue region or at multiple tissue regions.

FIG. 3A shows a partial cross-sectional view of an example where one ormore optical fiber bundles 32 may be positioned within the catheter andwithin imaging hood 12 to provide direct in-line imaging of the openarea within hood 12. FIG. 3B shows another example where an imagingelement 34 (e.g., CCD or CMOS electronic imager) may be placed along aninterior surface of imaging hood 12 to provide imaging of the open areasuch that the imaging element 34 is off-axis relative to a longitudinalaxis of the hood 12, as described in further detail below. The off-axisposition of element 34 may provide for direct visualization anduninhibited access by instruments from the catheter to the underlyingtissue during treatment.

In utilizing the imaging hood 12 in any one of the procedures describedherein, the hood 12 may have an open field which is uncovered and clearto provide direct tissue contact between the hood interior and theunderlying tissue to effect any number of treatments upon the tissue, asdescribed above. Yet in additional variations, imaging hood 12 mayutilize other configurations. An additional variation of the imaginghood 12 is shown in the perspective and end views, respectively, ofFIGS. 4A and 4B, where imaging hood 12 includes at least one layer of atransparent elastomeric membrane 40 over the distal opening of hood 12.An aperture 42 having a diameter which is less than a diameter of theouter lip of imaging hood 12 may be defined over the center of membrane40 where a longitudinal axis of the hood intersects the membrane suchthat the interior of hood 12 remains open and in fluid communicationwith the environment external to hood 12. Furthermore, aperture 42 maybe sized, e.g., between 1 to 2 mm or more in diameter and membrane 40can be made from any number of transparent elastomers such as silicone,polyurethane, latex, etc. such that contacted tissue may also bevisualized through membrane 40 as well as through aperture 42.

Aperture 42 may function generally as a restricting passageway to reducethe rate of fluid out-flow from the hood 12 when the interior of thehood 12 is infused with the clear fluid through which underlying tissueregions may be visualized. Aside from restricting out-flow of clearfluid from within hood 12, aperture 42 may also restrict externalsurrounding fluids from entering hood 12 too rapidly. The reduction inthe rate of fluid out-flow from the hood and blood in-flow into the hoodmay improve visualization conditions as hood 12 may be more readilyfilled with transparent fluid rather than being filled by opaque bloodwhich may obstruct direct visualization by the visualizationinstruments.

Moreover, aperture 42 may be aligned with catheter 16 such that anyinstruments (e.g., piercing instruments, guidewires, tissue engagers,etc.) that are advanced into the hood interior may directly access theunderlying tissue uninhibited or unrestricted for treatment throughaperture 42. In other variations wherein aperture 42 may not be alignedwith catheter 16, instruments passed through catheter 16 may stillaccess the underlying tissue by simply piercing through membrane 40.

In an additional variation, FIGS. 5A and 5B show perspective and endviews, respectively, of imaging hood 12 which includes membrane 40 withaperture 42 defined therethrough, as described above. This variationincludes a plurality of additional openings 44 defined over membrane 40surrounding aperture 42. Additional openings 44 may be uniformly sized,e.g., each less than 1 mm in diameter, to allow for the out-flow of thetranslucent fluid therethrough when in contact against the tissuesurface. Moreover, although openings 44 are illustrated as uniform insize, the openings may be varied in size and their placement may also benon-uniform or random over membrane 40 rather than uniformly positionedabout aperture 42 in FIG. 5B. Furthermore, there are eight openings 44shown in the figures although fewer than eight or more than eightopenings 44 may also be utilized over membrane 40.

Additional details of tissue imaging and manipulation systems andmethods which may be utilized with apparatus and methods describedherein are further described, for example, in U.S. patent applicationSer. No. 11/259,498 filed Oct. 25, 2005 (U.S. Pat. Pub. 2006/0184048A1), which is incorporated herein by reference in its entirety.

In utilizing the devices and methods above, various procedures may beaccomplished. One example of such a procedure is crossing a tissueregion such as in a transseptal procedure where a septal wall is piercedand traversed, e.g., crossing from a right atrial chamber to a leftatrial chamber in a heart of a subject. Generally, in piercing andtraversing a septal wall, the visualization and treatment devicesdescribed herein may be utilized for visualizing the tissue region to bepierced as well as monitoring the piercing and access through thetissue. Details of transseptal visualization catheters and methods fortransseptal access which may be utilized with the apparatus and methodsdescribed herein are described in U.S. patent application Ser. No.11/763,399 filed Jun. 14, 2007 (U.S. Pat. Pub. 2007/0293724 A1), whichis incorporated herein by reference in its entirety. Additionally,details of tissue visualization and manipulation catheter which may beutilized with apparatus and methods described herein are described inU.S. patent application Ser. No. 11/259,498 filed Oct. 25, 2005 (U.S.Pat. Pub. 2006/0184048 A1), which is incorporated herein by reference inits entirety.

In clearing the hood of blood and/or other bodily fluids, it isgenerally desirable to purge the hood in an efficient manner byminimizing the amount of clearing fluid, such as saline, introduced intothe hood and thus into the body. As excessive saline delivered into theblood stream of patients with poor ventricular function may increase therisk of heart failure and pulmonary edema, minimizing or controlling theamount of saline discharged during various therapies, such as atrialfibrillation ablation, atrial flutter ablation, transseptal puncture,etc. may be generally desirable.

FIGS. 6A and 6B show side views of one variation of an imaging hoodincorporating an internal diaphragm 50, which may be transparent,attached to the inner wall of the hood 12 about its circumference 54such that diaphragm 50 is suspended circumferentially within the hood12. The diaphragm 50 may be fabricated from a transparent elastomericmembrane similar to the material of hood 12 (such as polyurethane,Chronoflex™, latex, etc) and may define one or more apertures 52 throughwhich saline fluid introduced into hood 12 may pass through diaphragm 50and out through main aperture 42 to clear blood from the open fieldwithin hood 12. The one or more apertures 52 may have a diameter ofbetween, e.g., 1 mm to 0.25 mm.

Flow of the saline fluid out of the hood 12 through main aperture 42 maycontinue under relatively low fluid pressure conditions as saline isintroduced from the catheter shaft 16, through the diaphragm apertures52, and out of the main aperture 42, as shown in FIG. 6A. Upon theapplication of a relatively higher fluid pressure, the diaphragm 50 maybe pushed distally within hood 12 until it extends or bulges distally toblock the main aperture 42 until fluid flow out of the hood 12 isreduced or completely stopped, as shown in FIG. 6B. With aperture 42blocked, the hood 12 may retain the purging fluid within to facilitatevisualization through the fluid of the underlying tissue. Thus, hood 12may be panned around a target tissue region with sustained visualizationto reduce the amount of saline that is introduced into a patient's heartor bloodstream. Once the fluid pressure of the purging fluid is reduced,diaphragm 50 may retract to unblock aperture 42 and thus allow for theflow of the purging fluid again through diaphragm apertures 52 and mainaperture 42.

Another variation is shown in the side views of FIGS. 7A and 7B, whichshow an internal inflation member or pouch 60, which may be transparent,positioned within hood 12 which also controls the outflow of the purgedsaline based on fluid pressure. When internal inflation member of pouch60 is at least partially inflated via the purging fluid introducedwithin, an annular flow path 62 may be defined between an externalsurface of pouch 60 and an inner surface of hood 12, as illustrated inFIG. 7A. The purging fluid may be initially introduced into pouch 60 andthen flow through one or more apertures 64 defined along the surface ofpouch 60 and out through the main aperture of hood 12 to clear bloodtherefrom. Each of the one or more apertures 64 may have a diameterranging from, e.g., 1 mm to 0.25 mm, and the apertures 64 may be locatedalong a proximal side of the pouch 60 along the annular flow path 62 inapposition to an interior surface of hood 12. When the pressure of thepurging fluid is increased, the internal pouch 60 may expand intocontact against the inner surface of hood 12 to block flow path 62 andpouch apertures 64 against hood 12, as depicted in FIG. 7B, therebyreducing or stopping saline outflow from the imaging hood 12. As thefluid pressure of the purging fluid is reduced, the size of internalpouch 60 may retract to thus unblock apertures 64 and flow path 62 andagain allow for the flow of the fluid therethrough.

In yet another variation shown in the side view of FIG. 8, hood 12 maybe sectioned into a proximal chamber 74 and a distal chamber 76separated by a transparent diaphragm 70 suspended within the hood 12, aspreviously described. In this embodiment, one or more unidirectionalvalves 72 may be positioned over the diaphragm 70 through which thepurging fluid may flow from the proximal chamber 74 to the distalchamber 76 and through the main aperture. Because of the unidirectionalflow of the fluid through valves 72, the purging fluid may exit proximalchamber 74 but may not flow back through the valves 72. In this manner,while the main aperture on the base of the hood 12 may temporarily allowthe entry of blood back into the distal chamber 76, the blood isprevented from filling the entire hood 12 by the valves 72 and theproximal chamber 74 may be purged once to initially clear away blood toobtain optical clarity. Hence the volume required for constant clearingof opaque fluids, such as blood, is reduced thus reducing the amount ofsaline required to establish visualization. FIGS. 9A and 9B show detailcross-sectional side views of the one or more unidirectional valves 72.As shown in FIG. 9A, flow 82 from the proximal chamber 74 may openoverlapping valve leaflets 80, which extend distally into distal chamber76. Once the flow 82 is stopped or reduced, the backflow 84 from distalchamber 76 may collapse the valve leaflets 80 upon themselves, thusinhibiting backflow through the valves 72 and into proximal chamber 74,as shown in FIG. 9B.

As further shown in FIG. 8, one or more portions 78 of the hood supportstruts which extend at least partially within the distal chamber 76 maybe internally exposed such that the saline within the distal chamber 76can be electrically charged, such as with RF energy, when the supportstruts are coupled to an RF generator. This allows the salineencapsulated in the distal chamber 76 to function as a virtual electrodeby conducting the discharged energy to the underlying visualized tissuefor treatments, such as tissue ablation. Details of electrode ablationof visualized tissue which may be utilized with apparatus and methodsdescribed herein are described in further detail in U.S. patentapplication Ser. No. 12/118,439 filed May 9, 2008 (U.S. Pat. Pub.2009/0030412 A1), which is incorporated herein by reference in itsentirety.

FIGS. 10A and 10B show perspective and cross-sectional perspective viewsof yet another variation which incorporates an electrode 90, such asring-shaped electrode, within hood 12 which defines a central lumen 92therethrough. The central lumen 92 may define one or more fluidapertures 94 proximally of electrode 90 which open to the hood interiorin a circumferential pattern around an outer surface of lumen 92.Central lumen 92 may also be sized to allow for the introduction andadvancement of a fiberscope (or other instrument) therethrough. With thepositioning of, e.g., a fiberscope, within lumen 92 and its distal endpositioned adjacent to or distal to electrode 90, the distal opening oflumen 92 may be obstructed by the fiberscope. As the purging fluid 98 isintroduced through lumen 92 and flows in an annular space between thefiberscope and the lumen 92, the purging fluid may be forced to flowsideways into hood 12 through the one or more fluid apertures 94 whilethe distal opening of lumen 92 remains obstructed by the fiberscope. Thepurging fluid 98 forced through apertures 94 may flow 96 along theinterior surface of hood 12 in a uniform manner, e.g., much like a“shower head”, to uniformly purge blood (or other opaque fluids) fromwithin the hood 12, consequently reducing the amount of saline requiredto establish visualization. Moreover, creating such a flow effect mayprevent jets of the purging fluid from being purged distally in theevent that fluid pressure and flow rate becomes too high as such jets ofpurging fluid may directly exit the hood aperture without thoroughlypurging the hood 12.

FIG. 11 shows yet another variation of a hood incorporating one or moreprotrusions or projections 100 extending from a distal membrane overhood 12. These protrusions or projections 100 may extend distallyadjacent to a corresponding unidirectional valve 102 which hasoverlapping leaflets 104. The protrusions or projections 100 maycomprise hemispherical protrusions made of a transparent elastomericmaterial (e.g., can be the same or different material as the imaginghood 12). In use, as hood 12 is filled with the purging fluid, flowthrough the valves 102 is inhibited or prevented by the overlappingleaflets 104, as shown in the cross-sectional detail view of FIG. 12A.As the distal face of the hood membrane 40 is pressed against a surfaceof tissue T to be visualized and/or treated, the protrusions orprojections 100 pressing against the tissue surface may force the valveleaflets 104 to separate temporarily, thus allowing the passage ofsaline 106 out through the valves 102 to clear any blood within the hood12 as well as any blood between membrane 40 and the tissue surface, asshown in the side view of FIG. 12B. Lifting hood 12 from the tissue mayagain allow the valve leaflets 104 to coapt and thus close the valve toprevent the blood from re-entering the hood 12 thus effectively reducingthe amount of saline that is introduced into the patient's heart orbloodstream.

In yet another variation, FIG. 13 shows an imaging hood 12 which isconfigured to form a recirculating flow inside the hood 12. The purgingfluid may be introduced (e.g., injected) as well as withdrawn from theimaging hood 12 interior through two different lumens in the cathetershaft 16. For instance, the fluid may be introduced by an inlet lumen110 which injects the fluid along a first path into hood 12 while therecirculating fluid 114 may be withdrawn by suction through a separateoutlet lumen 112. By keeping a relatively higher volume flow rate ininlet lumen 110 for injecting the purging fluid than the flow rate inoutlet lumen 112 for withdrawing it, a considerable amount of purgingfluid may be conserved resulting in efficient hood purging.

FIG. 14 shows a side view of another variation incorporating a suctionlumen 120, e.g., a pre-bent lumen, extending from catheter 16 directlyto the main aperture 42. This particular variation may allow for thedirect evacuation of blood through a lumen opening 122 at a particularlocation along the main aperture 42 where the in-flow of blood (or otheropaque fluids) is particularly high. For instance, when visualizing apulmonary vein ostium in the left atrium of a patient's heart, theconstant in-flow of blood into the imaging hood 12 from the pulmonaryvein may occur. In order to overcome such a high in-flow rate, a higherflow rate or pressure of the purging fluid may be required to maintainvisualization consequently increasing the amount of saline dischargedinto the patient's body. With the suction lumen 120, visualization canbe achieved with a lower purging fluid flow rate or pressure when thesuction lumen 120 is extended slightly out of the main aperture 42 orwithin the main aperture 42 to evacuate the in-flowing blood. The lumenopening 122 of suction lumen 120 can also be moved around the aperturespace by torquing the suction lumen 120. The suction lumen 120 may alsobe used for evacuating any thrombosis or coagulated residue that may beformed during a therapeutic procedure, such as ablation.

Yet another variation is shown in the side view of FIG. 15 whichillustrates a hood 12 partitioned into multiple chambers, e.g., chambersA, B, C, D, which are in fluid communication with individualcorresponding fluid lumens defined through catheter 16. Each of thechambers A, B, C, D may be separated by corresponding transparentbarriers 132, 134, 136 which extend along the length of hood 12.Although four chambers are shown in this example, fewer than four orgreater than four chambers may be utilized. Each of the differentchambers A, B, C, D may have a corresponding aperture 130A, 130B, 130C,130D. The imaging element may be positioned inside the hood 12 to allowvisualization of the tissue region.

Efficient purging and reduction of saline discharged may achieved whenpurging can be selectively stopped once a particular chamber establishesoptical clarity. This can be done manually by the operator or throughautomation by a processor incorporated within the system. If automationis used, optical clarity of each individual chamber can be determined byquantifying the amount of red (co-related to amount of blood in chamber)through the Red:Green:Blue ratio of the image captured of a particularsector that corresponds to the particular chamber. FIG. 16 shows anexample of a flow chart for the automated selective purging ofindividual chambers A, B, C, D. As all of the chambers A, B, C, D areinitially purged 140, each chamber may be monitored as to whether it hasobtained sufficient optical clarity 142A, 142B, 142C, 142D, i.e.,whether a sufficient amount of blood (or other opaque bodily fluid) hascleared from the chamber to allow direct visualization of the underlyingtissue region as detected either by the operator or automatically. Ifthe respective chamber has not yet obtained sufficient optical clarity,the process of purging the chamber may be repeated or continued untilsufficient optical clarity has been reached. Once the sufficient levelof optical clarity has been reached, flow of the purging fluid into therespective chamber A, B, C, D may be stopped 144A, 144B, 144C, 144D. Asdifferent parts of the hood 12 may be cleared at different rates, flowof the purging fluid may be selectively stopped and/or continued indifferent chambers depending on the optical clarity and thus potentiallyreducing the amount of purging fluid released into the body.

In yet another variation, FIGS. 17A and 17B show side views of a hood 12which may incorporate an expandable distal membrane 150 which projectsdistally from hood 12 and is sufficiently soft to conform against theunderlying contacted tissue. As shown, distal membrane 150 may define anintermediate chamber 158 between membrane 154 of hood 12 and the distalmembrane 150. With membrane 154 defining one or more hood apertures 156,the purging fluid may enter within hood 12 and exit through hoodapertures 156 into intermediate chamber 158 which may extend distally asshown in FIG. 17A. The purging fluid may exit intermediate chamber 158through at least one central aperture 152. In the event that hood 12contacts against a surface of tissue T at a non-perpendicular angle, asindicated by angle of incidence θ defined between the catheterlongitudinal axis 160 and tissue surface, distal membrane 150 mayconform to the tissue surface despite the angle of incidence θ. Asresult, distal membrane 150 may still establish contact with the tissueyielding a more efficient purging effect, as shown in FIG. 17B.

In yet another variation, as shown in the side view of FIG. 18, animaging hood 12 may have distal membrane without an aperture and whichmay be filled with the purging fluid once desirably positioned withinthe subject's body in proximity to the tissue region to be visualizedand/or treated. As the distal membrane is closed, the underlying tissuemay be contacted and visualized through the hood 12. Once a tissueregion to be treated has been located by hood 12, a piercing instrument,such as a transseptal or transmural needle 170, may be advanced throughhood 12 from catheter 16 to puncture through the distal membrane at adesired site. This may form a puncture aperture 172 through which thepurging fluid may escape 174. Hence, purging is only performed atlocations where instruments are passed out of the imaging hood 12 thusreducing the amount of saline discharged out of the hood 12. A pluralityof puncture apertures can be made across the distal membrane accordingto the needs of the procedure or the operator. Details of transseptalneedles which may be utilized with apparatus and methods describedherein are described in U.S. patent application Ser. No. 11/763,399filed Jun. 14, 2007 (U.S. Pat. Pub. No. 2007/0293724 A1), which has beenincorporated hereinabove. Details of transmural needles which may beutilized with apparatus and methods described herein are described inU.S. patent application Ser. No. 11/775,837 filed Jul. 10, 2007 (U.S.Pat. Pub. No. 2008/0009747 A1), which is incorporated herein byreference in its entirety.

The applications of the disclosed invention discussed above are notlimited to certain treatments or regions of the body, but may includeany number of other treatments and areas of the body. Modification ofthe above-described methods and devices for carrying out the invention,and variations of aspects of the invention that are obvious to those ofskill in the arts are intended to be within the scope of thisdisclosure. Moreover, various combinations of aspects between examplesare also contemplated and are considered to be within the scope of thisdisclosure as well.

What is claimed is:
 1. A method of inhibiting a flow of a purging fluidfrom a tissue visualization device, the method comprising: positioningan imaging hood attached to a distal end of a flexible elongate shaft inproximity to a tissue region to be visualized; introducing the purgingfluid into an inflation member suspended within an open area of theimaging hood, the inflation member including at least one aperture on aproximal portion of the inflation member; inflating the inflation memberto a partially inflated state in which the purging fluid inflates theinflation member such that the inflation member is circumferentiallyseparated from an inner surface of the hood to form an annular flow pathfor the purging fluid from the at least one aperture, between the innersurface of the hood and the inflation member, and into fluidcommunication with an environment external to the hood; and inflatingthe inflation member to a blocking inflated state in which the inflationmember expands into contact with the imaging hood to block the flow fromthe at least one aperture to the annular flow path.
 2. The method ofclaim 1 wherein inflating the inflation member includes inflating aconically shaped inflation member.
 3. The method of claim 2 wherein theimaging hood has a conical shape.
 4. The method of claim 1 furthercomprising purging blood from the imaging hood to the environmentexternal to the hood with the flow of purging fluid.
 5. The method ofclaim 1 further comprising visualizing tissue underlying the hood via animaging element positioned within or along the hood.
 6. The method ofclaim 1 wherein the hood comprises a distal membrane which defines amain aperture, the method further comprising dispensing the purgingfluid through main aperture to the environment external to the hood. 7.The method of claim 6 wherein the distal membrane is transparent.
 8. Themethod of claim 1 wherein the flow of the purging fluid passes throughthe flexible elongate shaft.
 9. The method claim of 1 wherein the atleast one aperture has a diameter between 1 mm and 0.25 mm.
 10. Themethod of claim 1 further comprising reducing a fluid pressure of thepurging fluid to withdraw the inflation member from contact with theimaging hood and unblock the flow from the at least one aperture.